LEVITRA Drug Patent Profile

Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levitra

A generic version of LEVITRA was approved as vardenafil hydrochloride by TEVA PHARMS on May 3^rd, 2012.

Summary for LEVITRA

International Patents:	54
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	25
Patent Applications:	5,200
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LEVITRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVITRA
What excipients (inactive ingredients) are in LEVITRA?	LEVITRA excipients list
DailyMed Link:	LEVITRA at DailyMed

See drug prices for LEVITRA

See drug sales revenues for LEVITRA

Recent Clinical Trials for LEVITRA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tritech Biopharmaceuticals Co., Ltd.	Phase 1/Phase 2
A2 Healthcare Taiwan Corporation	Phase 1/Phase 2
Azienda USL Modena	Phase 2

See all LEVITRA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LEVITRA

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for LEVITRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEVITRA	Tablets	vardenafil hydrochloride	2.5 mg	021400	1	2009-09-04
LEVITRA	Tablets	vardenafil hydrochloride	5 mg and 10 mg	021400	1	2009-07-10
LEVITRA	Tablets	vardenafil hydrochloride	20 mg	021400	1	2009-03-05

US Patents and Regulatory Information for LEVITRA

LEVITRA is protected by two US patents.

Patents protecting LEVITRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003		DISCN	Yes	No
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003		DISCN	Yes	No			Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003		DISCN	Yes	No			Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No			Y
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003		DISCN	Yes	No
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003		DISCN	Yes	No			Y

Expired US Patents for LEVITRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003

International Patents for LEVITRA

See the table below for patents covering LEVITRA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	513431
Cuba	23473	MEDICAMENTOS QUE CONTIENEN CLORHIDRATO DE VARDENAFILO TRIHIDRATO
Ukraine	85542	ЛЕКАРСТВЕННЫЕ СРЕДСТВА, СОДЕРЖАЩИЕ ГИДРОХЛОРИД ВАРДЕНАФИЛА, И СПОСОБ ИХ ПРИГОТОВЛЕНИЯ;ЛІКАРСЬКІ ЗАСОБИ, ЩО МІСТЯТЬ ТРИГІДРАТ ГІДРОХЛОРИДУ ВАРДЕНАФІЛУ ТА СПОСІБ ЇХ ВИГОТОВЛЕННЯ (METHOD FOR PRODUCING MEDICAMENTS CONTAINING VARDENAFIL HYDROCHLORIDE)
World Intellectual Property Organization (WIPO)	9924433
Spain	2378358
World Intellectual Property Organization (WIPO)	2004006894
United Kingdom	0010974